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Normosol-R Inj
Normosol-R is a balanced crystalloid intravenous fluid that replaces electrolytes and fluid volume to maintain physiological homeostasis.
Normosol-R is a balanced crystalloid intravenous fluid that replaces electrolytes and fluid volume to maintain physiological homeostasis. Used for Fluid and electrolyte replacement in dehydration and hypovolemia, Perioperative fluid management, Maintenance of electrolyte balance in hospitalized patients.
At a glance
| Generic name | Normosol-R Inj |
|---|---|
| Sponsor | Nationwide Children's Hospital |
| Drug class | Crystalloid intravenous fluid |
| Modality | Small molecule |
| Therapeutic area | Critical Care / Fluid Management |
| Phase | Phase 3 |
Mechanism of action
Normosol-R is a sterile, nonpyrogenic crystalloid solution containing sodium, potassium, magnesium, chloride, acetate, and gluconate in concentrations designed to approximate plasma electrolyte composition. It is used for fluid and electrolyte replacement in patients with dehydration, hypovolemia, or electrolyte imbalances, helping to restore intravascular volume and maintain normal osmotic balance without the hyperchloremic acidosis associated with normal saline.
Approved indications
- Fluid and electrolyte replacement in dehydration and hypovolemia
- Perioperative fluid management
- Maintenance of electrolyte balance in hospitalized patients
Common side effects
- Hypervolemia (fluid overload)
- Hyponatremia
- Hyperkalemia
- Phlebitis at infusion site
Key clinical trials
- Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP Pancreatitis (PHASE4)
- Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Normosol-R Inj CI brief — competitive landscape report
- Normosol-R Inj updates RSS · CI watch RSS
- Nationwide Children's Hospital portfolio CI